A Study In Healthy Volunteers To Estimate The Effect Of The Active Ingredient Particle Size And Percentage Of The Excipients Used To Formulate The Capsules In The Dissolution Rate Of The Formulations In The Gastrointestinal Tract
Public ClinicalTrials.gov record NCT01844323. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1, Open-Label 4 Sequence 4 Period Crossover Study In Healthy Volunteers To Estimate The Effect Of Active Pharmaceutical Ingredient Particle Size And Lubrication On The Bioavailability Of A Single 125 Mg Dose Of Palbociclib (PD-0332991) Administered Under Fasted Conditions
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The particle size of the active ingredient may impact dissolution rate in the gastro intestinal tract and hence the amount of drug available for absorption. Similarly, differences in the percentage of the excipients used in the formulated capsules may affect dissolution rate. The purpose of this study is to estimate the effect that particle size and percentage of excipients could have in drug absorption, which will improve the manufacturing process of the formulated capsules.
Study identification
- NCT ID
- NCT01844323
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 24 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 55 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 31, 2013
- Primary completion
- Jul 31, 2013
- Completion
- Jul 31, 2013
- Last update posted
- Aug 27, 2013
2013
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Pfizer Investigational Site | New Haven | Connecticut | 06511 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Recently updated Healthy trials
Other public records listing Healthy. Sorted by last update posted; newest first. Not a recommendation.
- NCT07792941: A Study to Learn About the Single Dose Pharmacokinetics of Study Medicine Called Tilrekimig in Healthy Adults When Co-Mixed With rHuPH20 Not yet recruiting
- NCT07748351: A Clinical Trial of Multiple Formulations of MK-4082 in Healthy Overweight and Obese Participants (MK-4082-007) Not yet recruiting
- NCT07776665: A Clinical Trial of Enlicitide (MK-0616) Formulations in Healthy Participants (MK-0616-044) Recruiting
- NCT07595263: A Study of Ulonivirine (MK-8507) and Methadone in Healthy Volunteers (MK-8507-019) Not yet recruiting
- NCT07677163: A Clinical Trial of MK-1403 in Healthy Participants (MK-1403-007) Recruiting
- NCT07767487: A Study of LY4226695 in Healthy Participants Not yet recruiting
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01844323, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 27, 2013 · Synced Sep 10, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01844323 live on ClinicalTrials.gov.